FSI renders its services on project basis where each client is given the unique attention needed to address its needs.  Though much of our work is project-based, for some clients, we assume all regulatory responsibilities for a fixed monthly fee under our Outsourced Regulatory Affairs (ORA) department. Our experienced team of experts in GMP & GDP compliance work will help you to develop regulatory strategies that optimize the likelihood of approvals, minimize cost and increase speed to market. In many cases, we   design and execute these strategies, providing literature & market research, develop regulatory submissions and documents to meet key FDA requirements.